ACRA

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

Completes study and site management activities as defined in task matrix, and
Functions as applicable and advised for study assigned.
• Completes and details study-specific training.
• Orients and trains on any study-specific systems.
• Provides in-house support during pre-study assessments and with pre-study
assessment waivers, as agreed for project.
• Supports to customize Site ICF with site contact details, as needed.
• Performs remote review of EMR/EHR checklist and supports collection, as
applicable assessments.
• Verifies document collection and RCR submission status; updates site EDL and
verifies site information.
• Reviews patient facing materials and review translations, as advised.
• Supports site staff with the vendor related qualification process, where
applicable.
• Provides support by ensuring system access is requested/granted and revoked
for relevant site staff during pre-activation and subsequent course of the study.
• Provides support to follow-up on site staff training, as applicable.
• Coordinates and supports logistics for IM attendance, as advised.
• Supports maintenance of vendor trackers, as advised.
• Coordinates study/site supply management during pre-activation and subsequent
course of the study.
• Supports Crucial Document collection, review and updating in systems, as
applicable.
• Follows up and supports on missing study vendor data like ECGs, lab samples,
and e-diaries, as advised.
• Supports ongoing remote review of centralized monitoring tools, as advised.
• Supports Site payments processes by coordinating with various functional
departments within organization and site. Supports system updates and
reconciliations, as advised and follows-up on site invoices throughout the study
period.
• Performs reconciliation tasks on assigned trials including but not limited to CRF
and query status, deviations, SAEs and safety reports, as applicable.
• Verifies document collection status in company systems and drives action for
missing/incomplete/expired documents and open document findings, as directed.

EducationandExperience:
Bachelor's degree in a life science rigor or related field or a Registered Nursing certification or 
equivalent and relevant formal academic / vocational qualification.
In some cases an equivalency, consisting of a combination of appropriate education, training 
and/or directly related experience, will be considered sufficient for an individual to meet the 
requirements of the role.
Knowledge,Skills andAbilities:
• Basic medical/therapeutic area knowledge and understanding of medical terminology
• Ability to attain and maintain a solid understanding of ICH GCP, applicable regulations and company
procedural documents
• Effective oral and written communication skills
• Excellent interpersonal and customer service skills
• Good interpersonal and time management skills and strong attention to detail, with shown ability to
balance multiple tasks efficiently and optimally
• Shown flexibility and adaptability
• Ability to work in a team or independently, as the need arises
• Well-developed critical thinking skills, including but not limited to critical attitude, in-depth
investigation for appropriate root cause analysis and problem solving
• Proficient digital literacy with good knowledge of MS Office ability to learn and use appropriate
software. Leverage modern technology when applicable
• Ability to extract pertinent information from all study documents, electronic study data systems,
CTMS and dashboards
• Excellent English language and grammar skill